Regulatory Writing - Volume 22, Issue

The recent publication of the book Bad Pharma by Ben Goldacre1 has caused quite a stir in the medical writing community (and indeed throughout the pharmaceutical industry).

Writing Matters - Volume 21, Issue

Writing matters to medical writers … or at least it should. But sometimes we are more consumed with the content of a document than the writing itself. And some might even argue that detailed medical or scientific information cannot be written as…

Biostatistics, data management, and medical writing: A multidisciplinary approach to the development of the CTD integrated summaries - Volume 29, Issue

Analyses of integrated databases of efficacy and safety are a Food and Drug Administration (FDA) requirement. They are very useful in evaluating the safety and efficacy data gathered in multiple clinical studies. However, their utility is dependent…

A beginner´s guide to writing clinical investigation plans and reports for medical devices - Volume 31, Issue

A clinical investigation plan for a medical device must outline and justify all objectives of the clinical investigation, present and justify the investigational design and methodology, and state principal features of  the statistical analysis. A…

Medical Education - Volume 25, Issue

Medical education implies providing education or training of unbiased scientific or medical content. However, the reality is that medical education is now more a spectrum of educational activities that span from more promotional to purely…

Post-approval regulatory writing - Volume 23, Issue

Manuscript Writing - Volume 27, Issue

Preparing clear, convincing scientific manuscripts is a challenge. In my experience, the biggest problem for most writers is not an inability to write well in English but rather a lack of clarity regarding what their article is supposed to be about.…

Writing economically in medicine and science: Tips for tackling wordiness - Volume 26, Issue

Concise medical and scientific writing is clearer, more direct, and more pleasurable to read than wordy text. It is also more accessible to readers, including those outside the discipline and non-native speakers of  English. An added benefit of…

Writing for Patients - Volume 29, Issue

The first thing we must say is a huge “thank you” to Dr Juan Garcia Burgos and Mr Paul Blake for taking the time in an unprecedentedly manic year for the EMA to write a foreword for this issue of Medical Writing. The fact that they have prioritised…

Manuscript Writing - Volume 21, Issue

Guidelines for manuscript writing: Here to help Although sometimes maligned, guidelines make manuscript writing easier and increase the chances of getting published. A good set of guidelines can be used as a checklist (many even include…